Table 3:
Treatment-emergent adverse events regardless of attribution
| Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | |
|---|---|---|---|---|
| Any treatment-emergent adverse event | 77 (99%) | 33 (42%) | 4 (5%) | 2 (3%) |
| Fatigue | 32 (41%) | 1 (1%) | 0 | 0 |
| Diarrhoea | 21 (27%) | 0 | 0 | 0 |
| Pruritus | 21 (27%) | 0 | 0 | 0 |
| Nausea | 17 (22%) | 0 | 0 | 0 |
| Cough | 15 (19%) | 0 | 0 | 0 |
| Abdominal pain | 11 (14%) | 0 | 0 | 0 |
| Rash* | 10 (13%) | 0 | 0 | 0 |
| Vomiting | 9 (12%) | 1 (1%) | 0 | 0 |
| Actinic keratosis | 8 (10%) | 0 | 0 | 0 |
| Anaemia | 8 (10%) | 1 (1%) | 0 | 0 |
| Back pain | 8 (10%) | 0 | 0 | 0 |
| Constipation | 8 (10%) | 0 | 0 | 0 |
| Dry skin | 8 (10%) | 0 | 0 | 0 |
| Hypothyroidism | 8 (10%) | 0 | 0 | 0 |
| Maculopapular rash* | 8 (10%) | 0 | 0 | 0 |
| Arthralgia | 7 (9%) | 1 (1%) | 0 | 0 |
| Basal cell carcinoma | 7 (9%) | 1 (1%) | 0 | 0 |
| Dyspnoea | 6 (8%) | 1 (1%) | 0 | 0 |
| Hypokalaemia | 5 (6%) | 1 (1%) | 0 | 0 |
| Pain in extremity | 5 (6%) | 1 (1%) | 0 | 0 |
| Wound infection | 5 (6%) | 1 (1%) | 0 | 0 |
| Dizziness | 4 (5%) | 1 (1%) | 0 | 0 |
| Increased aspartate aminotransferase | 4 (5%) | 1 (1%) | 0 | 0 |
| Skin infection | 4 (5%) | 1 (1%) | 0 | 0 |
| Urinary tract infection | 4 (5%) | 2 (3%) | 0 | 0 |
| Fall | 3 (4%) | 2 (3%) | 0 | 0 |
| Hyperglycaemia | 3 (4%) | 3 (4%) | 0 | 0 |
| Neck pain | 3 (4%) | 1 (1%) | 0 | 0 |
| Pain | 3 (4%) | 1 (1%) | 0 | 0 |
| Pneumonitis | 3 (4%) | 1 (1%) | 2 (3%) | 0 |
| Squamous cell carcinoma of skin | 3 (4%) | 1 (1%) | 0 | 0 |
| Hypertension | 2 (3%) | 6 (8%) | 0 | 0 |
| Hyponatraemia | 2 (3%) | 2 (3%) | 0 | 0 |
| Hypotension | 2 (3%) | 1 (1%) | 0 | 0 |
| Muscular weakness | 2 (3%) | 2 (3%) | 0 | 0 |
| Musculoskeletal pain | 2 (3%) | 2 (3%) | 0 | 0 |
| Cellulitis | 1 (1%) | 3 (4%) | 0 | 0 |
| Hypophosphataemia | 1 (1%) | 1 (1%) | 0 | 0 |
| Influenza | 1 (1%) | 1 (1%) | 0 | 0 |
| Lymphopenia | 1 (1%) | 2 (3%) | 0 | 0 |
| Pneumonia | 1 (1%) | 3 (4%) | 1 (1%) | 1 (1%) |
| Soft tissue infection | 1 (1%) | 1 (1%) | 0 | 0 |
| Squamous cell carcinoma | 1 (1%) | 1 (1%) | 0 | 0 |
| Atopic dermatitis | 0 | 1 (1%) | 0 | 0 |
| Autoimmune hepatitis | 0 | 1 (1%) | 0 | 0 |
| Breast cancer | 0 | 2 (3%) | 0 | 0 |
| Cholecystitis | 0 | 1 (1%) | 0 | 0 |
| Clostridium difficile colitis | 0 | 1 (1%) | 0 | 0 |
| Death | 0 | 0 | 0 | 1 (1%) |
| Device-related infection | 0 | 1 (1%) | 0 | 0 |
| Encephalitis | 0 | 1 (1%) | 0 | 0 |
| Extradural abscess | 0 | 1 (1%) | 0 | 0 |
| Facial neuralgia | 0 | 1 (1%) | 0 | 0 |
| Hepatitis | 0 | 1 (1%) | 0 | 0 |
| Hip fracture | 0 | 1 (1%) | 0 | 0 |
| Increased international normalised ratio | 0 | 1 (1%) | 0 | 0 |
| Increased lipase | 0 | 1 (1%) | 0 | 0 |
| Increased weight | 0 | 1 (1%) | 0 | 0 |
| Myocardial infarction | 0 | 0 | 1 (1%) | 0 |
| Myocarditis | 0 | 1 (1%) | 0 | 0 |
| Nasal cavity cancer | 0 | 1 (1%) | 0 | 0 |
| Positive influenza A virus test | 0 | 1 (1%) | 0 | 0 |
| Pneumonia influenza | 0 | 1 (1%) | 0 | 0 |
| Proctitis | 0 | 1 (1%) | 0 | 0 |
| Psoas abscess | 0 | 1 (1%) | 0 | 0 |
| Radius fracture | 0 | 1 (1%) | 0 | 0 |
| Sepsis | 0 | 1 (1%) | 1 (1%) | 0 |
| Staphylococcal infection | 0 | 1 (1%) | 0 | 0 |
| Subdural haematoma | 0 | 1 (1%) | 0 | 0 |
| Syncope | 0 | 1 (1%) | 0 | 0 |
| Upper abdominal pain | 0 | 1 (1%) | 0 | 0 |
| Urinary tract obstruction | 0 | 1 (1%) | 0 | 0 |
| Wound complication | 0 | 1 (1%) | 0 | 0 |
Data are n (%) in all treated patients. Treatment-emergent adverse events, regardless of attribution, reported in at least 10% of patients (grades 1–2) or by any patient (grades 3–5) are shown.
*
Although rash and maculopapular rash might reflect the same condition, they were listed as two distinct events for the safety report of the study.